Date: October 9, 2018
Subject: FSAP Policy Statement: Select agent contained in formalin-fixed paraffin-embedded tissue
The Federal Select Agent Program (FSAP) is a collaboration between the Centers for Disease Control and Prevention, Division of Select Agents and Toxins and the Animal and Plant Health Inspection Service, Agriculture Select Agent Services to regulate the possession, use, and transfer of biological agents and toxins listed in 7 C.F.R. Part 331, 9 C.F.R. Part 121, and 42 C.F.R. Part 73 (select agents and toxins). The FSAP administers the select agent regulations in close coordination with the Federal Bureau of Investigation’s Criminal Justice Information Services Division (CJIS).
FSAP has determined that a select agent or regulated nucleic acids that can produce infectious forms of any select agent virus contained in a formalin-fixed paraffin-embedded (FFPE) tissue has been effectively inactivated if the FFPE process used is a recognized method (e.g. a previously published method shown to be effective such that validation does not have to occur in-house for FFPE tissues) for that particular agent or regulated nucleic acids. It is therefore the policy of the FSAP that such material is not subject to the select agent regulations found in 7 C.F.R. Part 331, 9 C.F.R. Part 121, or 42 C.F.R. Part 73.
This policy statement is effective October 9, 2018.
Sections 3(d)(6) and 4(d)(6) of the select agent regulations allow for the exclusion from the requirements of the select agent regulations of a select agent sample that has not been subjected to a validated inactivation procedure or material containing a select agent that has not been subjected to a procedure that removes all viable select agent cells, spores, or virus particles if the HHS Secretary or the APHIS Administrator determines that a process used on the select agent sample or material containing a select agent has been effectively inactivated the select agent sample or that all the select agent has been effectively removed from the material.